[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53773-53774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21191]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0920]
Select Updates for Non-Clinical Engineering Tests and Recommended
Labeling for Intravascular Stents and Associated Delivery Systems;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Select Updates for Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular
Stents and Associated Delivery Systems.'' FDA has developed this
guidance to inform the coronary and peripheral stent industry about
selected updates to FDA's thinking regarding certain non-clinical
testing for these devices. While FDA is considering more substantial
updates to the ``Non-Clinical Engineering Tests and Recommended
Labeling for Intravascular Stents and Associated Delivery Systems''
guidance (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm), we are
issuing this update on select sections in order to notify the industry
in a timely manner of our revised recommendations. This draft guidance
is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 30, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Select Updates for Non-Clinical
Engineering Tests and Recommended Labeling for Intravascular Stents and
Associated Delivery Systems'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Lindsay Pack, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg.66, Rm. 1270, Silver Spring, MD 20993-0002, 301-796-5214; or
Erica Takai, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg.62, Rm. 3226, Silver
Spring, MD 20993-0002, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
FDA held a public workshop entitled ``Cardiovascular Metallic
Implants: Corrosion, Surface Characterization, and Nickel Leaching'' on
March 8 and 9, 2012, that provided information on current practices for
performing these tests (see http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm287535.htm). A group of participants
from industry, test facilities, and academia provided comments on
practices for corrosion testing and nickel ion release testing. Based
on the discussion at the workshop, this draft guidance updates a key
aspect of sample conditioning for pitting corrosion testing that is
less burdensome, and includes additional information on when galvanic
corrosion testing may be omitted with justification, based on
information gained from the workshop. This guidance provides updates
only for the following topics:
Pitting corrosion potential;
Galvanic corrosion;
Surface characterization; and
Nickel ion release.
This draft guidance provides cross-references and updates to the
related sections of the existing ``Non-Clinical Engineering Tests and
Recommended Labeling for Intravascular Stents and Associated Delivery
Systems'' guidance. Following the close of the comment period on this
guidance, FDA intends to consider the comments received, revise this
draft guidance as appropriate, and publish it in final. Simultaneously,
FDA will issue an update to the existing guidance to add cross-
references where this selected updates guidance supersedes the existing
recommendations. Subsequently, FDA will incorporate the elements of the
final select updates guidance into an anticipated revision of the
entire ``Non-Clinical Engineering Tests and Recommended Labeling for
Intravascular Stents and Associated Delivery Systems'' guidance.
This draft guidance also lists the relevant product codes for
stents addressed in the guidance. Of note is that the product code NXP
(Stent, Tibial), which is not currently listed in the existing ``Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular
Stents and Associated Delivery Systems'' guidance, has been added. This
product code was not created until after the current guidance was
published, however, the recommendations in this draft guidance are
applicable to tibial stents. Further, FDA will include this product
code in the anticipated revision of the entire ``Non-Clinical
Engineering Tests and Recommended Labeling for Intravascular Stents and
Associated Delivery Systems'' guidance.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on certain non-
clinical testing for coronary and peripheral stents. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.
To receive ``Select Updates for Non-Clinical Engineering Tests and
Recommended Labeling for Intravascular Stents and Associated Delivery
Systems,'' you may either send
[[Page 53774]]
an email request to dsmica@fda.hhs.gov to receive an electronic copy of
the document or send a fax request to 301-847-8149 to receive a hard
copy. Please use the document number 1826 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: August 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21191 Filed 8-29-13; 8:45 am]
BILLING CODE 4160-01-P